MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA, TIBIAL IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBAL UKA, TIBIAL IMPACTOR
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 01/24/2023 by a distributor via sems that an ar-611-4 tibial impactor broke while being impacted.Case involvement, device broke during use.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-611-4 batch number 052202, was received for investigation.Visual evaluation found that the head tibial impactor broken off before receipt for investigation.No fragments were returned for analysis.Additional observation also found signs of wear.The root cause of the reported failure mode is undetermined; however, the observed event is most likely caused by excessive forces applied during use.

• Brand Name: IBAL UKA, TIBIAL IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16361757
• Report Number: 1220246-2023-06270
• Device Sequence Number: 15301419
• Product Code: LXH
• UDI-Device Identifier: 00888867223868
• UDI-Public: 00888867223868
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IBAL UKA, TIBIAL IMPACTOR
• Device Catalogue Number: AR-611-4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown